MAUDE Adverse Event Report: SYNTHES GMBH 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 03.010.502

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the two devices listed were incorrectly connected by the scrub tech and are now stuck together and could not be separated.There was no patient consequences.This report is for one (1) 13.0 protection sleeve for rafn retro/qc.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 13.0 PROTECTION SLEEVE FOR RAFN RETRO/QC
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18054733
• MDR Text Key: 327145531
• Report Number: 8030965-2023-13732
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982069191
• UDI-Public: (01)10886982069191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 6NM TORQUE LIMITING BLUE HNDL 6 HEX COUP.